VAXEAL HOLDING SA | COMPANY AND TECHNOLOGY OVERVIEW | OCTOBER 2011 Company & Technology Overview July, 2013 www.vaxeal-­‐group.com VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW OVERVIEW v SME founded in 2009 -­‐ Headquartered in Vevey (CH) + Affiliates in France (R&D) and China v Development of novel generaZon of Long Synthe7c Pep7de-­‐based therapeu7c vaccines in combinaZon with immunomodulatory drugs v Focus on large market opportuniZes with MAJOR global paZent unmet medical needs: 1) Cancer: Survivin, Midkine and CBX-­‐1 2) Infec)ous diseases: HepaZZs C genotype 1 – 6 v Strong IP Posi7on : 4 licensed patents + 2 pending patents v Seed Investment: 3 million € + Founders money + 15 years academic investment v Strategic Academic Partners 2 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW EXECUTIVE TEAM Dr Ahmed Bouzidi, PhD, MBA – CEO SCIENTIFIC ASSOCIATES Pr Eric Tartour, MD, PhD – Immuno-­‐Oncology -­‐ Successful entrepreneur in Europe and China -­‐ Board member of EBE-­‐Biopharma -­‐ Member of the R&D Task Force of Vaccines Europe -­‐ Director of the cancer immunomonitoring department of HEGP (Paris) -­‐ Director of an Inserm team dedicated to cancer immunotherapy -­‐ Clinical development of several cancer immunotherapies Mr Serge Grisard, Msc, MBA, EVP Corporate Development Pr Pedro Romero, MD, PhD – Immuno-­‐Oncology -­‐ 18 years experience in Healthcare product development, CommercializaZon and PPPs -­‐ Global management at Siemens Medical, Pfizer, Astra-­‐Zeneca, and a range of private start-­‐ups Pr Giampietro Corradin, PhD – CTO -­‐ Worldwide expert in LSP-­‐based vaccines (30 years experience) -­‐ Development of several vaccine candidates Dr Jérôme Kerzerho, PhD – Director R&D -­‐ Expert in immunology -­‐ Discovered the tumor anZgens Midkine -­‐ IdenZfied new clinically relevant T cell epitopes in Survivin and Midkine tumor anZgens -­‐ Wordlwide Oncology expert at Ludwig insZtute -­‐ ElucidaZon of the immunological mechanisms of cancer therapeuZc vaccines -­‐ Laureate of the Robert-­‐Wenner award in 2001 (best Swiss researcher) Dr Bernard Maillère, PhD, Eng. – Immunology -­‐ Director of the department of immunochemistry of cellular immune response at the CEA (FR) -­‐ Developed the PredicZve plahorm of Vaxeal Pr François Sper7ni, MD, PhD – Virology -­‐ Expert in vaccine clinical development -­‐ Focused on the development of novel vaccine strategies in the field of hepaZZs C, tuberculosis, Malaria and allergy 3 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW ADVANCED PROPRIETARY TECHNOLOGY PLATFORMS FOR… IMMUNOGENICITY PREDICTION & T CELL EPITOPE IDENTIFICATION PRODUCTION / FORMULATION/ COMBINATIONS ü A rapid idenZficaZon of relevant T cell epitopes to be incorporated in a vaccine ü The design, formulaZon and validaZon of the vaccine candidates ü Pre-­‐clinical proof of concept studies PRE-­‐CLINICAL VALIDATION IMMUNO-­‐MONITORING OF CLINICAL TRIALS ü The evaluaZon of synergisZc combinaZon of the formulated vaccines with immunomodulatory agents ü The immunomonitoring of clinical trials VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW VAXEAL -­‐ PIPELINE PRODUCT( ( Survivin(( (SVX01)!(1)( LEAD( OPTIMIZATION( INDICATION( ( ! PRE0CLINICAL( P0o0C( Q1(2014! !! !! Midkine(( NSCLC,(Colorectal,(Breast( and(Ovarian(cancers( (MDX01)!(2)( Multiple(Cancers( Combo((1+2+3)( Multiple(Cancers( ( !! !! !! !! ( ! Core/NS3( Hepatitis(C(gen.1/6(( MARKET( POTENTIAL( PARTNERS( ! Prostate,(Renal(and( Pancreas(cancers,( Metastatic(melanoma( CBX01((3)( PHASE(I( (I/II)( ! Q3(2014( Q1(2015( >(€5bn/(year! INSERM( 0( Ludwig! >(€5bn/(year! >(€5bn/(year! ! >(€5bn/(year! Q3(2016( ! ! Q1(2014! ! CMC! ! ! ! >(€5bn/(year! ! 5 VAXEAL HOLDING SA | COMPANY AND TECHNOLOGY OVERVIEW | OCTOBER 2011 ONCOLOGY PROGRAM VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW MAIN ISSUES IN TRADITIONAL CANCER VACCINE-­‐BASED APPROACHES Difficulty in achieving the right balance of CD4+ and CD8+ T cells -­‐ Short pepZdes-­‐, Weak Immunogenicity ü As vaccine target of self or dispensable anZgens ü Short pepZde based-­‐vaccines induce T cell anergy as they are presented by non APC protein-­‐ and DNA-­‐based vaccines mainly induce either CD4+ or CD8+ T cells TRADITIONAL)CANCER)VACCINE)) (Short'Pep+des.,'Recombinant'Proteins.'&' Vector'Delivery.based'Vaccines)' Restricted efficacy to certain ++) cancer indicaZons or paZents HLA types Vaccine>mediated) immunosupression) Tumor-­‐mediated immunosupressive mechanisms ü Treg inducZon ü Overexpression of cosZmulatory inhibitory molecules (PD-­‐L1…) ü Tumor-­‐mediated angiogenesis +/>) Tumor)–)induced) Tolerance) Safety and Cost of Vaccines created from living organisms Tumor) Immunosurveillance) Impaired)an+tumoral) immune)responses) Limited longevity of the elicited an7-­‐tumoral responses leading to impaired protecZon against tumor relapses Need to op7mize tradi7onal therapeu7c cancer vaccine design to increase their clinical efficacy 7 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW VAXEAL -­‐ BREAKTHROUGH STRATEGY OF THERAPEUTIC CANCER VACCINE Vaxeal developed an innova7ve combined strategy of cancer vaccine enabling to overcome the limitaZons to current vaccine approaches COMPONENTS)OF)VAXEAL’S)CANCER) THERAPEUTIC)VACCINES) Long)Synthetic)Peptides)(LSP)Dbased)vaccine! encompassing:! ! Multiple!promiscuous!CD4+!and!CD8+!T! epitopes!! ! Derived!from!broadly!overexpressed!tumor! antigens!playing!vital!functions! ADVANTAGES) Generate)longDterm)and)high)affinity)CD4+)and)CD8+)antiDtumoral)T)cell) responses!in!all!of!the!cancer!patients!irrespective!of!their!HLA!types! Limit)tumor)immune)escape!thanks!to!the!tumor!restricted!expression! profile!and!vital!functions!of!the!tumor!antigen!target! Optimized)formulation)with!potent)clinicalD approved)immuneDadjuvant! Improve)the)polarization)and)longevity!of!the!induce!T!cell!responses! Synergistic)combination)with)clinicalDapproved) advanced)immunomodulatory)drugs) Overcome)tumourDmediated)immunosuppression) ! Low!doses!chemotherapy! ! AntiDangiogenic!drugs!!>#For#hypervascular#tumors! ! Others!advanced!immunomodulatory!drugs! ! ! 8 VAXEAL | COMPANY AND TECHNOLOGY OVERVIEW VAXEAL CANCER VACCINE -­‐ COMPETITIVE ADVANTAGES Short&Pep,des& Recombinant& Proteins& Vector&delivery& (e.g.%DNA%plasmide,% viral%vector,..)% ★★★% 7% ★★% ★★★% ★★★% ★★★% ★% ★★% ★★★% Applicability&a&broad&target& popula,on/cancers& ★ ★ ★% ★★% 7% ★★% ★★% Induc,on&of&longBlas,ng& protec,on&against&relapse& ★ ★ ★% ★★ % ★% ★ ★% ★★ % Overcome&of&tumorBinduced& immunosuppressive& mechanisms&(T&cell&exhaus,on)& ★★★% 7% 7% 7% 7% Safety& ★★★% ★★★% ★★★% ★★% ★% Ease&of&produc,on&and& purifica,on& ★★★% ★★★% ★★★% ★% ★% Stability& ★★★% ★★★% ★★★% Protein&dependent& Vector&dependent& Clinical&efficacy& ★ ★ ★% ★★% 7% ★% ★★% Vaxeal&Therapeu,c& Vaccines& LSPs& Immunogenicity& ★★★% Specificity& -­‐ Nul, ★ Poor, ★★ Moderate, ★★★ OpZmal 9 VAXEAL HOLDING SA | COMPANY AND TECHNOLOGY OVERVIEW | OCTOBER 2011 THANK YOU For more information… Website: www.vaxeal-­‐group.com Contact: [email protected]